GILDAGIA norethindrone and ethinyl estradiol

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)

متاح من:

Par Pharmaceutical

INN (الاسم الدولي):

NORETHINDRONE

تركيب:

NORETHINDRONE 0.4 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

GILDAGIA- NORETHINDRONE AND ETHINYL ESTRADIOL
PAR PHARMACEUTICAL
----------
GILDAGIA (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 0.4
MG/0.035 MG) 28 DAY REGIMEN
RX ONLY
Patients should be counseled that this product does not protect
against HIV-infection (AIDS) and other
sexually transmitted diseases.
DESCRIPTION
28 DAY Gildagia™ (norethindrone and ethinyl estradiol tablets USP,
0.4 mg/0.035 mg) provides a
continuous regimen for oral contraception derived from 21 tablets
composed of norethindrone and
ethinyl estradiol to be followed by 7 light-green tablets of inert
ingredients. The structural formulas
are:
The peach active tablets each contain 0.4 mg norethindrone and 0.035
mg ethinyl estradiol, and contain
the following inactive ingredients: FD&C Yellow #6 HT (aluminum lake),
hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, and pregelatinized
starch. The light-green tablets in the 28 Day regimen contain only
inert ingredients as follows: FD&C
Blue #2, hypromellose, iron oxide yellow, lactose monohydrate,
magnesium stearate, polyethylene
glycol, and pregelatinized starch.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins.
Although the primary mechanism
of this action is inhibition of ovulation, other alterations include
changes in the cervical mucus (which
increase the difficulty of sperm entry into the uterus) and the
endometrium (which reduce the likelihood
of implantation).
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in
women who elect to use this
product as a method of contraception. Oral contraceptives are highly
effective. TABLE 1 lists the
typical accidental pregnancy rates for users of combination oral
contraceptives and other methods of
contraception. The efficacy of these contraceptive methods, except
sterilization, depends upon the
reliability with which they are used. Correct and consistent use of
methods can result in lower failure
rates.
TM
TABLE 1: LOWE